BR112012001488A2 - processes for mitigating loss of functional status. - Google Patents

Abstract

Functional Status Loss Mitigation Processes The present invention relates to nutritional compositions and methods of using nutritional compositions with exercise to mitigate the loss of functional status that are provided. In a general embodiment, the present disclosure provides a nutritional composition including buttermilk protein, and vitamin d. Nutritional composition and exercise can be specifically used to alleviate the loss of functional status, especially in the elderly.

Description

Invention Patent Descriptive Report for FUNCTIONAL STATUS LOSS ATTENUATION PROCESSES.

Cross Reference for Related Patent Applications

The present patent application claims the benefit of a previous U.S.61 / 226 806 provisional patent application filed on July 20, 2009 and a previous U.S. provisional patent application 61/334 247 filed on May 13, 2010.

Detailed Description

As used herein, fence, it is preferably understood to refer to numbers in a range of numerals. In addition, all numeric ranges here must be understood to include any integer, integral or fractions within the range.

As used herein, the term amino acid is preferably understood to include one or more amino acids. The amino acid can be alanine, arginine, asparagine, aspartate, citrulline, cysteine, glutamate, glutamine, glycine, histidine, hydroxy proline, hydroxy serine, hydroxy tyrosine, hydroxy lysine, isoleucine, leucine, lysine, methionine, phenyl alanine, proline, serine , taurine, threonine, tryptophan, tyrosine, and valine or a combination thereof, and can be included with an embodiment of the invention.

As used herein, the term antioxidant is preferably understood to include any one or more of several substances (such as beta carotene (a precursor to vitamin A), vitamin C, vitamin E, and selenium) that inhibit oxidation or reactions promoted by Reactive Oxygen Species ( ROS) and other radical and non-radical species. In addition, antioxidants are molecules capable of decreasing or preventing the oxidation of other molecules. As used herein, non-limiting examples of antioxidants include corotenoids, coenzyme Q10 (CoQ10), flavonoids, Goji glutathione (Wlfberry), hesperidin, Lactowolfberry, lignan, lutein, lycopene, polyphenols, selenium, vitamin A, vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, and combinations thereof, and can be included in an embodiment of the invention.

As used herein, effective quantity is preferably a

2/34 amount that avoids a deficiency, treats a disease or medical condition in an individual or, more generally, reduces symptoms, manages disease progress or provides a nutritional, physiological or medical benefit to the individual. A treatment can be related to a patient or doctor. In addition, although the terms individual and patient are often used herein to refer to a human, the invention is thus not limited. Likewise, the terms individual and patient refer to any animal, mammal or human having or at risk for a medical condition that may benefit from treatment.

As used herein, mammals include but are not limited to rodents, aquatic mammals, domestic animals such as dogs and cats, farm animals such as sheep, pigs, cows and horses, and humans. Where the term mammal is used, it is contemplated that it is also applied to other animals that are capable of the effect exhibited or intended to be exhibited by the mammal.

As used herein, animals include, but are not limited to, mammals which include but are not limited to rodents, aquatic mammals, domestic animals such as dogs and cats, farm animals such as sheep, pigs, cows and horses and humans. Where the terms animal or mammal or its plurals are used, it is contemplated that they also apply to any animals that are capable of the effect exhibited or intended to be exhibited by the context of the passage.

As used herein, the elderly is preferably a human who is sixty-five years of age or older, more preferably 75 years of age or older.

As used herein, the term patient is preferably understood to include an animal, especially a mammal, and more especially a human who is receiving or intended to receive treatment, as defined herein.

As defined herein, short-term administrations are preferably continuous administrations for less than 6 weeks.

As used herein, long-term administrations are preferably continuous administrations for more than 6 weeks.

As used herein, complete nutrition is preferably nutritional products that contain sufficient levels of macronutrients (protein, fats and carbohydrates) and micronutrients to be sufficient as the sole source of nutrition for the animal to which they are being administered.

As used herein, incomplete nutrition is preferably nutritional products that do not contain sufficient levels of macronutrients (protein, fats, and carbohydrates) or micronutrients to be sufficient to be the sole source of nutrition for the animal to which they are administered.

As used herein, a tube feed is preferably a complete or incomplete nutritional product that is administered to an animal's gastrointestinal system, other than through oral administration, including but not limited to a nasogastric tube, oral gastric tube, orifice, such such as a chest wall orifice that provides access to the stomach, fasting and other appropriate access orifices, and / or Percutaneous Endoscopic Gastrostomy (PEG).

As used herein the term minerals is preferably understood to include boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, and combinations thereof. included in an embodiment of the invention.

As used herein, the term vitamin is preferably understood to include any of a number of organic fat-soluble or water-soluble substances (non-limiting examples include vitamin A, vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin or niacinamide) , vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folic acid), and vitamin B12 (various cobalamines; commonly cyanocobalamin in vitamin supplements) , vitamin C, vitamin D, vitamin E, vitamin K, folic acid and biotin) essential in minor amounts for normal growth and activity of the body and obtained naturally from animal and plant foods or manufactured synthetically, pro-vitamins, derivatives, analogs, and

4/34 can be included in an embodiment of the invention.

As used herein, the terms treatment and treat are preferably for both prophylactic or preventive treatment and treatment of cure or modification of disease, including treatment of patients at risk of contracting the disease or suspected of having contracted the disease, as well as patients who are sick or have been diagnosed as suffering from an illness or medical condition. The terms treatment and treat also refer to maintaining and / or promoting health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition, such as nitrogen imbalance or muscle loss.

Nutritional products are preferably further understood to include any number of optional additional ingredients, including conventional food additives, for example, one or more, acidulants, additional thickeners, buffers or pH adjusting agents, chelating agents, dyes, emulsifiers, excipients, flavoring agents , mineral, osmotic agents, a pharmaceutically acceptable carrier, preservatives, stabilizers, sugar, sweeteners, texturizers, and / or vitamins. Optional ingredients can be added in any appropriate amount.

As used herein, whey protein is intended to include protein micelles, whey protein concentrate, whey protein hydrolysates, and whey protein isolate and combinations thereof.

Muscle loss. There are two factors that contribute to the loss of muscle mass and also the loss of muscle function. However, it is important to note that muscle mass and function are not necessarily correlated.

The first factor is a depression in protein synthesis. Decreases in synthesis can occur in people with suboptimal nutrition, but also in sedentary people with adequate diet. Lower levels of protein synthesis are also a natural process of aging.

The second factor contributing to loss of muscle mass (and muscle function) is accelerated catabolism. Both disease and injury insult to the body or tissues are mechanisms that increase muscle breakdown. Inflammation caused by damage, illness, or even aging is also included as initiators of muscle breakdown.

Skeleton muscle is a state of constant flow with approximately equal degrees of muscle development and muscle breakdown. If either of these two conditions is changed, the total amount of muscle mass is affected.

Individuals who have suffered an accident, stroke, generic illness, frail elderly, etc., can be confined to their beds. The loss of muscle contraction activity reduces the body's signals for protein synthesis. Because the muscle remodeling process occurs continuously, the loss of protein synthesis with constant muscle breakdown tilts the balance in the direction of net muscle loss. The three mechanisms are physical activity, nutrition and pharmaceutical compounds.

In the elderly, as well as in recovering patients, walking and other weight-carrying activities are sufficient to release mioD protein to activate satellite cells for muscle repair and reconstruction. Increased activity in addition to walking results in greater benefits. In addition to muscle, activity stimulates the generation of more mitochondria within myocytes, which are necessary for energy production to maintain muscle function. Muscle usage is considered to be the best process available for maintaining and growing muscle and function. Disuse results in atrophy.

On the other hand, disease and infections can increase the rate of catabolism that collapses muscle. In this case, the balance deviates in favor of muscle loss despite normal protein synthesis. Muscle breakdown can be the result of elevated inflammatory cytokines or the use of muscle proteins as an energy source. Protein is a source

6/34 easily available energy and malnutrition can cause these stocks to be quickly mobilized, unlike fat tissue that takes much longer.

The correlation between loss of muscle mass or function or muscle morbidity is well known. The patient's prognosis, probability of getting a nosocomial infection, length of hospital stay are all correlated to the patient's muscle mass. A decrease in muscle mass and function can not only reduce physical activity, but have metabolic effects including decreased bone density, obesity, and impaired glucose tolerance. A loss of approximately 3-5% of muscle mass per decade has been shown to occur after the age of 30, although this decline is greatest after the age of 60 or older.

Systemic inflammation, including subclinical inflammation, in the elderly is part of the etiology of sarcopenia. It has recently been reported that high CRP (inflammatory marker) and low hemoglobin have been associated with decreased muscle resistance, interleukin-6 and CRP, but not TNFalpha, are reported elsewhere to correlate with physical function. These subclinical levels of inflammation often go unreported and continue to cause a decline in patient functionality until significant muscle is lost.

Pharmacological agents, such as anabolic steroid hormones and growth hormone, are occasionally prescribed when endogenous levels of growth hormone and androgens decrease with age. However, these agents can also put the patient at risk of developing serious complications that include initiation of cancer. Nutritional interventions are believed to provide an effective treatment program without the risks associated with drug therapy.

Physical interventions like walking, climbing stairs, getting up from a chair, and carrying loads are functional activities that deteriorate with muscle loss. The loss of type II muscle fibers results in decreased resistance and the ability to generate energy. There is a sig

7/34 nificant correlation between resistance and leg energy and maximum walking speed and height of climbing stairs. Rantanen and Avela described critical leg energy ranges for different walking speeds, suggesting that below the critical range the probability of walking at a particular speed is low. Interventions have been investigated that include pharmaceutical compounds, aerobic exercise, and specific compounds.

Selecting an appropriate physical intervention is critical to success. Resistance training does not appear to be effective in preserving muscle mass and improving sarcopenia progression.

Benefits of engaging in regular resistance training include an increase in basal metabolism and limb perfusion, bone mineral density, as well as improved sensitivity to insulin profiles, and lipids and lipoproteins. Although the list of benefits induced by resistance training is impressive, the magnitude of these health benefits may be substantially less than those obtained through resistance training, and there are also many unfavorable effects associated with resistance training.

Recent studies have reported that individuals habitually undergoing resistance training exhibit a higher age-related arterial stiffness rate and that a period of energetic resistance training increases arterial stiffness. Because arterial stiffness precedes and may even start the development of high blood pressure, resulting in hypertension that often leads to a major clinical event, these findings are alarming. Fortunately, resistance training concomitantly performed with resistance training seems to negate the effects of arterial stiffness in resistance training. This exercise regime is consistent with the current recommendation for physical activity to do both, persistence and resistance training on a daily basis. Other comparative studies have shown that the combination of resistance training and persistence results in better cardiovascular adaptation than persistence training alone, especially in the population of older cardiac patients.

However, it is known that heavy exercise causes increased calcium loss through sweat and the body does not compensate for this by reducing the loss of calcium in the urine. The result may be a net loss of calcium large enough to present health concepts for menopausal women.

One study found that the use of a cheap calcium supplement (calcium carbonate), taken at a dose of 400 mg twice a day, is sufficient to compensate for this loss.

Oxidizing stress is increased during exercise and the potential damage to elderly tissues is likely to increase cellular damage that signals proteolytic remodeling to correct damage.

Nutrition as a solution for tissues in therapeutic exercise: There are specific nutrients that are reported to increase protein synthesis and have been used, as limited success, to promote retention or development of lean muscle mass.

The most notable include: branched chain amino acids (BCAAs) (valine, leucine, and isoleucine). BCAAs can be administered in their free forms. As dipeptides, as tripeptides, as polypeptides, as a protein rich in BCAA, and / or as a protein engineered to enrich the BCAA content. Dipeptides, tripeptides and polypeptides can include two or more BCAAs. When non-BCAAs are included in a preferred amino acid dipeptide, tripeptide, or polypeptide, includinguemalanine and glycine, but non-BCAAs can be any of the dispensable or indispensable (essential and non-essential) amino acids. For example, preferred dipeptides include, but are not limited to, alanyl - leucine, alanyl - isoleucine, alanyl - valine, glycyl - leucine, glycyl - isoleucine, and glycyl - valine. Leucine precursors, such as pyruvate, and metabolites, such as alpha-hydroxy isocaproate, -hydroxy methyl butyrate and alpha keto isocaproate, whey protein (includes whey protein with high leucine content); creatine; antioxidants including bioactive such as lycopene, pycnogenol; quercetin. Antioxidants that can influence mitochondria include: 9/34 in: genistein (soybean, epigallocatechin (green tea), lipoic acid (ALA), Xtocopherol, dihydro ascorbic acid (Vi C), and ubiquinone (Coenzyme Q10).

Age-related changes in amino acid metabolism that are linked to muscle loss can be overcome through

1) supplementation of excess leucine in the diet, 2) increased protein intake or 3) exercise, which improves the activation of translation initiation and muscle protein synthesis. Leucine has poor organoleptic properties and is therefore difficult to supplement orally, so dipeptides, polypeptides, leucine precursors, leucine metabolites and proteins with a high leucine content are the preferred administration processes.

Somatopause is the process of reduced growth hormone and IGF-1 as we age. This reduction in important anabolic hormones leads to reduced lean body mass (sarcopenia) and bone mineral density (osteopenia, osteoporosis). Certain dietary factors such as high protein diets as well as Zn and Cu diets have been shown to help increase IGF in serum. In addition, the composition provides other important nutrients such as high levels of vitamin D that synergistically increase the effectiveness of other anabolic hormones such as insulin (note that when we age, we also become resistant to insulin). For this reason, the unique combination of these key nutrients will synergistically create a favorable physiological response leading to improved total muscle - skeletal health. The combination of such a formulation with resistance exercise will also lead to synergistic benefits not realized with an equivalent amount of essential amino acids, or other key ingredients alone.

Vitamin D in skeletal muscle activates the protein kinase C signaling molecule which results in subsequent release of calcium, increasing the pool of calcium, which is essential for skeletal muscle contraction. In addition, animal data indicate that exogenous 25-OH increases skeletal muscle protein synthesis. Administration of vitamin D in deficient rats

It resulted in increased muscle mass, weight gain, and

10/34 a decreased rate of myofibrillar protein degradation. These findings are corroborated by studies of human biopsies that compared muscle biopsies of patients deficient in vitamin D, pre- and post-supplementation of vitamin D. Biopsies demonstrated atrophy of type II muscle fibers pre-supplementation while significant improvements were observed after supplementation ( type II muscle fibers are a type of skeletal muscle used for short bursts of energy and speed).

Clinical studies have suggested that vitamin D insufficiency is associated with poor lower extremity performance. Several randomized controlled intervention experiments have found that vitamin D supplementation in amounts that bring the level of vitamin D 25-OH in the average serum of the treated group to 66-84 nmoles / L improves the performance of lower extremity muscle in the elderly. In addition, serum vitamin D 25-OH was the common contributor to fitness indexes (android fat mass, lean mass, balance, hand grip resistance) in healthy menopausal women. The proposed nutritional formula will seek to significantly increase circulating levels of Vitamin D 25-OH in serum in the elderly using a low-volume, concentrated approach.

Exercise increases the energy required by the cell. Oxidizing phosphorylation to create ATP results in the generation of free radicals (eg, superoxide) that can damage cells. Athletes who generate high amounts of these oxidizing radicals typically have both good nutrition and good endogenous antioxidant levels (superoxide dismutases, glutathione, etc.) needed to control exercise-induced damage. Older and sick people lack the ability to defend themselves effectively against these radicals. free. Glutathione (Gln-Cys-Gly), is an intracellular antioxidant produced by the body from three amino acids. Limiting the supply of glutamine, cysteine (cystine) or glycine will reduce glutathione synthesis and levels. The use of whey protein is a source of cysteine (cystine).

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Physical interventions that include strategies for promoting protein synthesis in a nutritionally compromised patient will result in potentially negative results. Protein synthesis increases the demand for amino acids to create new proteins. If dietary protein intake is inadequate to meet the demands, muscles and other protein-rich tissues are degraded to release amino acids. The elderly, patients recovering from harm, etc., are at the highest risk when their nutritional intakes, particularly protein, are well documented to be sub-optimal.

Exercise-induced oxidative phosphorylation increases oxygen consumption by the cell (for example, contracting muscle cells). When oxygen supply is inadequate to support this energy production process, the body switches to anaerobic metabolism. The result of what is lactate production. The elderly patient, recovering, etc. it does not reach a level of performance that limits oxygen supply as athletes, but poor circulation, low hemoglobin levels, chronic conditions including COPD all limit O2 transport capacity. As a result, lactate production decreases the pH of muscle causing the clinic's sub-acute metabolic acidosis. Beta alanine, a metabolic buffer within cells, can be supplemented in the diet of these individuals to reduce tension on the muscle.

The prior art teaches that dietary interventions, including high protein, have not been entirely successful in improving physical function. Nutrition is a stimulant of protein synthesis, but inadequate to obtain a clinically relevant difference. The combination of a specific exercise program and specific nutritional intervention suggests that the benefits of each treatment modality can be synergistic.

Although protein requirements for elderly individuals have recently been confirmed by the Institute of Medicine to be similar for adults 55 years and younger (0.8 g / kg / d; Food and Nutrition Board and Institute of Medicine, 2002), Campbell et al. (1994) verified that I

12/34 elderly people fed an isoenergetic diet with the recommended protein (0.8 g / kg / d) for 2 weeks reduced N excretion and hermetic - medium muscle area. The results suggest that the recommendation is not adequate to satisfy the metabolic requirements of healthy elderly people. Nutritional interventions for the prevention and treatment of sarcopenia are exciting as a result of easy applicability and safety, but attempts to improve muscle mass in the elderly with protein supplementation have been largely unsuccessful.

Adequate nutrition is vital to assist bone repair and prevent falls, particularly in malnourished patients. Vitamin D, calcium and protein supplementation are associated with an increase in hip bone mineral density and a reduction in falls. Rehabilitation is essential to improve functional disabilities and survival rates. Fall prevention and functional recovery strategies should include education and patient training to improve balance and increase muscle endurance and mobility.

An intervention for sarcopenia and physical frailty that includes nutrition can also benefit from the inclusion of vitamins and minerals, including zinc, magnesium, folate, vitamin C and B12. Corotenoids are of particular interest in the nutritional interventions described for improving physical function.

Timing of nutritional supplementation also plays a role in the effectiveness that can be obtained from the combination of exercise and nutrition. The use of nutrition as a stimulant for protein synthesis and recovery has been described for proteins and energy, but not for vitamins, minerals, and bioactive components. In order for the antioxidant components to minimize damage they have to be administered early enough to be bioactive in the individual during and after exercise. Therefore, a supplement releases the greatest benefit between 30 minutes and 1 hour before exercise and less than 1 hour to 30 minutes after. Ideally, nutritional interventions are released between 30 minutes before or after exercise.

Pulsed feeding of the nutritional supplement several times a

13/34 days in conjunction with meals and / or following exercise is a preferred release process. Release of a concentrate or higher level of protein typically consumed in a meal will raise blood amino acid levels (ie, branched chain amino acids) and allow an anabolic threshold to be reached at which to increase fractional rates of protein synthesis in skeletal muscle . The stimulation of protein synthesis has to be sufficient so that in the context of metabolized amount of protein (ie synthesis - collapse) the liquid anabolic response is positive and eventually leads to an accretion of lean mass over time. In addition, ingestion of the nutritional product following exercise will further increase the anabolic response given the increased blood flow and improved perfusion of nutrients (ie, amino acids) to the skeletal muscle in elderly individuals.

American College Sports Medicine exercise recommendation: A combination of endurance and persistence (aerobic) exercise can provide additional benefits for the individual who is not entirely accomplished by acquiescing to one or the other alone.

ACSM / AHA Physical Activity Recommendations: Persistence Exercise for Older Adults:

• Frequency: moderate intensity activities, accumulated for at least 30 or up to 60 (for greater benefit) minutes / d in explosions of at least 10 minutes each for a total of 150-300 minutes / week, at least 20-30 minutes / d or more of vigorous intensity activities for a total of 75-150 minutes / week, an equivalent combination of moderate and vigorous activity.

• Intensity: On a scale of 0-10 for exercise level, 5-6 for moderate intensity and 7 to 8 for vigorous intensity.

• Duration: For moderate intensity activities, accumulate at least 30 minutes / day in explosions of at least 10 minutes each or at least 20 minutes / day of continuous activity for vigorous intensity activities.

Type: Any modality that does not impose excessive tension or

Topedic 14/34; walking is the most common type of activity. Water exercise and stationary cycle exercise can be advantageous for those with limited tolerance for weight-bearing activity.

Resistance exercise for older adults:

• Frequency: At least 2 d / s • Intensity: between moderate (5-6) and vigorous (7-8) intensity on a scale from 0 to 10.

• Type: Progressive weight training program or weight-carrying calisthenics (8-10 exercises involving the main muscle groups of 8-12 repetitions each), climbing stairs, and other stiffening activities that use the main muscle groups .

Flexibility exercise for older adults:

• Frequency: at least 2 d / s.

• Intensity: Moderate intensity (5-6) on a scale from 0 to

10.

• Type: Any activities that maintain or increase flexibility using sustained stretches for each major muscle group and static before ballistic movements.

Rocking exercise for those who fall frequently or individuals with mobility problems: ACSM / AHA guidelines recommend rocking exercise for individuals who fall frequently or with mobility problems due to the lack of adequate research evidence.

Exercise Prescribing Guidelines recommend using activities that include the following:

1) progressively difficult postures that gradually reduce the support base (for example, standing on two legs, standing semitandem, standing tandem, standing one-leg), 2) dynamic movements that disturb the center of gravity (for example, walking tandem, turns in circles), 3) stressful postural muscle groups (eg standing on heels, standing on tiptoes), or 4) reduced sensory input (eg standing with eyes closed).

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The ACSM / AHA guidelines recommend the following special considerations when prescribing exercise and physical activity for older adults. The intensity and duration of physical activity should be low at the beginning for older adults who are highly deconditioned, functionally limited, or have chronic conditions that affect their ability to perform physical tasks. The progression of activities must be individual and tailored to tolerance and preference; a conservative approach may be necessary for most older adults who are physically limited and unconditioned. Muscle tightening and / or swing training activities may be necessary to precede aerobic training activities among very fragile individuals. Elderly adults should exceed the recommended minimum amounts of physical activity if they wish to improve their fitness. If chronic conditions prevent activity to the minimum recommended amount, older adults should perform physical activities as tolerated in order to avoid being sedentary.

The release of nutritional compositions for animals, such as human patients, who cannot orally ingest food or other forms of nutrition is often of critical importance. For example, feeding tubes that deposit food directly into the gastrointestinal tract at a point below the mouth are often used to sustain life while a patient is unable, or refuses, to take oral food. Feed tubes and other artificial delivery systems and routes can be used temporarily when treating acute conditions. For chronic conditions, such systems and routes can be used as part of a treatment regimen that lasts for the rest of the patient's life. No matter the duration of use, these devices often provide the patient's only means of feeding.

In a preferred embodiment, the nutritional intervention will contain at least one of: protein, carbohydrate, fiber, fat, fatty acid, vitamin, mineral, sugar, and flavoring agent.

In one embodiment, the nutritional intervention will contain a

16/34 liquid. A liquid thickener is an additive that will increase the viscosity of a nutritional intervention to assist those patients who can benefit from a thickened liquid, such as that patient who has dysphagia. Many liquid thickeners are known in the art, but some examples include xanthan gum, guar gum, locust bean gum, and a gum tare, gum tamarind, gum tragacanth, gum caraia, konkak mannan, sodium CMC, sodium alginate, pectin, azotobacter BINERANJIGAMU, carrageenan, an agar, gellant gum, a furcellaran,

Gelatin, curdlan, cassia gum, a psyllium seed gum, CMC carageenan, beta glycan, modified starch, and starch.

A preferred embodiment of the nutritional intervention includes a formulation of a nutritional product with a high protein content (35-60% of total calories) provided as whey protein. The form of whey protein may be whey protein micelles of whey or concentrate or whey protein isolate. The composition will also provide 10-30% of total calories as carbohydrates and 20-40% of total calories as fat. The protein component is inherently high in branched-chain amino acids (leucine, valine, isoleucine) that have been shown to stimulate muscle synthesis. An advantage of providing these amino acids in this form is that it not only avoids the adverse sensory impact of added amino acids, but also creates a favorable physiological response due to the high protein composition.

Another preferred embodiment of the nutritional intervention includes a formulation of a nutritional product with a high protein content (35-60% of total calories in the composition) provided as whey protein micelles. The composition will also provide 10-30% of total calories as carbohydrates and 20-40% of total calories as fat.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention; and

b) an exercise regime.

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In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps prevent loss of muscle mass; and

b) an exercise regime

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps prevent muscle mass loss, said nutritional intervention comprising: buttermilk protein; creatine; antioxidants including bioactive such as lycopene, pycnogenol; quercetin; genistein; Soy; catechin epigalo; green tea; lipoic acid; Alpha lipoic acid; X-tocopherol; dihydro ascorbic acid; Vitamin C; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy isocaproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; nucleotides or any combinations thereof, and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps prevent sarcopenia; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to prevent sarcopenia, said nutritional intervention comprising: vitamins; minerals; zinc; magnesium; folate; vitamins C; Vitamin B12, buttermilk protein; creatine; antioxidants including bioactive such as lycopene, pycnogenol; quercetin; genistein; Soy; catechin epigalo; green tea; lipoic acid; Alpha lipoic acid; X-tocopherol; dihydro ascorbic acid; Vitamin C; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy isocaproate, beta

18/34 hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor of BCAA, a metabolite of BCAA; a BCAA-rich protein; a protein engineered to enrich the BCAA content; nucleotides or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps prevent loss of muscle function; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps prevent loss of muscle function, said nutritional intervention comprising corotenoids; vitamin D including vitamin D3, 1,25-dihydroxy Vitamin D, 25hydroxy Vitamin D; whey protein or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce inflammation; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce inflammation, said nutritional intervention comprising vitamin C; omega-3 fatty acid; Lactowolfberry or its combinations; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce inflammation

19/34 subclinical; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce subclinical inflammation; said nutritional intervention comprises vitamin C, omega-3 fatty acids, lactowolfberry or their combinations; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce calcium loss; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce calcium loss, said nutritional intervention comprising vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25-hydroxy vitamin D; calcium; whey protein and protein or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce oxidative stress; and

b) an exercise regime.

In a preferred embodiment of the invention the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce oxidative stress, said nutritional intervention comprising antioxidants; and

b) an exercise regime.

In a preferred embodiment of the invention the loss of functional status mitigation processes comprising:

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a) a nutritional intervention that helps reduce oxidative stress, said nutritional intervention comprising superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce free radicals; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce free radicals, said nutritional intervention comprising antioxidants; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce free radicals, said nutritional intervention comprising superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce lactic acid;

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps to reduce lactic acid, said nutritional intervention comprising beta alanine; and

b) an exercise regime.

In a preferred embodiment of the invention, the processes for up to 21/34 loss of functional status comprising:

a) a nutritional intervention that helps promote protein synthesis; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps promote protein synthesis, said nutritional intervention comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; vitamin B12, creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce protein catabolism; and

b) an exercise program.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention that helps reduce protein catabolism, said nutritional intervention comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; vitamin B12, creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; xtocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy

22/34 beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof; and

b) an exercise regime.

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention, where said nutritional intervention comprises at least two of:

1) a nutritional intervention that helps prevent loss of muscle mass;

2) a nutritional intervention that helps prevent sarcopenia;

3) a nutritional intervention that helps prevent loss of muscle function;

4) a nutritional intervention that helps reduce inflammation;

5) a nutritional intervention that helps to reduce subclinical inflammation;

6) a nutritional intervention that helps to reduce calcium loss;

7) a nutritional intervention that helps to reduce oxidative stress;

8) a nutritional intervention that helps reduce free radicals;

9) a nutritional intervention that helps reduce lactic acid;

10) a nutritional intervention that helps promote protein synthesis;

11) a nutritional intervention that helps reduce protein catasbolism; and

b) an exercise regime.

23/34

In a preferred embodiment of the invention, the loss of functional status mitigation processes comprising:

a) a nutritional intervention, where said nutritional intervention comprises at least two of:

1) a nutritional intervention that helps to reduce muscle mass loss, said nutritional intervention comprising: whey protein, creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof;

2) a nutritional intervention that helps prevent sarcopenia, said nutritional intervention comprising: vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof;

3) a nutritional intervention that helps prevent loss of muscle function, said nutritional intervention comprising corotenoids; vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25hydroxy vitamin D; whey protein or any combination thereof;

4) a nutritional intervention that helps reduce inflammation, said nutritional intervention comprising Vitamin C; fatty acids

24/34 omega-3s; Lactowolfberry or its combinations;

5) a nutritional intervention that helps to reduce subclinical inflammation, said nutritional intervention comprising Vitamin C; omega-3 fatty acids; Lactowolfberry or its combinations;

6) a nutritional intervention that helps reduce calcium loss, said nutritional intervention comprising vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25-hydroxy vitamin D; calcium; whey protein and protein or any combination thereof;

7) a nutritional intervention that helps to reduce oxidative stress, said nutritional intervention comprising superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof.

8) a nutritional intervention that helps in the reduction of free radicals, said nutritional intervention comprising antioxidants; superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof;

9) a nutritional intervention that helps to reduce lactic acid, said nutritional intervention comprising beta alanine;

10) a nutritional intervention that assists in promoting protein synthesis, said nutritional intervention comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof;

11) a nutritional intervention that helps to reduce protein catabolism, said nutritional intervention comprising

25/34 vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof; and

b) an exercise regime.

A benefit of at least one preferred embodiment of the invention is that the risk of morbidity is reduced.

In a preferred embodiment of the invention, nutritional intervention is complete nutrition.

In a preferred embodiment of the invention, nutritional intervention is incomplete nutrition.

In a preferred embodiment of the invention, the nutritional intervention is for short term administration.

In a preferred embodiment of the invention, the nutritional intervention is for long-term administration.

In a preferred embodiment of the invention, the nutritional intervention is tube feeding.

In a preferred embodiment of the invention, the nutritional intervention is a gel.

In a preferred embodiment of the invention, the nutritional intervention is a concentrated liquid.

In a preferred embodiment of the invention, the nutritional intervention is a dense liquid nutrient.

In a preferred embodiment of the invention, the nutritional intervention further comprises a liquid thickener.

In a preferred embodiment of the invention, the nutritional intervention still comprises a liquid thickener.

In a preferred embodiment of the invention, the nutritional intervention will be administered in a dose starting from about an hour before the exercise regimen to about an hour after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in more than one dose starting from about an hour before the exercise regimen to about an hour after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in a dose starting from about 45 minutes before the exercise regimen to about 45 minutes after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in more than one dose starting from about 45 minutes before the exercise regimen to about 45 minutes after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in a dose starting from about 30 minutes before the exercise regimen to about 30 minutes after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in more than one dose starting from about 30 minutes before the exercise regimen to about 30 minutes after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in a dose starting from about 15 minutes before the exercise regimen to about 45 minutes after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in more than one dose starting from about 15 minutes before the exercise regimen to about 45 minutes after the exercise regimen.

In a preferred embodiment of the invention, the nutritional intervention will be administered in a dose starting from about 15 minutes before the exercise regimen to about 30 minutes after the exercise regimen.

27/34

In a preferred embodiment of the invention, the nutritional intervention will be administered in more than one dose starting from about 15 minutes before the exercise regimen to about 30 minutes after the exercise regimen.

In a preferred embodiment of the invention, nutritional intervention will still provide hydration.

In a preferred embodiment of the invention, nutritional intervention will prevent dehydration.

In a preferred embodiment of the invention, nutritional intervention will prevent or decrease increased age-related arterial stiffness due to an exercise regime.

In a preferred embodiment of the invention, the exercise regime comprises persistence training.

In a preferred embodiment of the invention, the exercise regime comprises resistance training.

In a preferred embodiment of the invention, the exercise regime comprises persistence training and resistance training.

In a preferred embodiment of the invention, the exercise regimen is sufficient to release mioD protein.

In a preferred embodiment of the invention, the exercise regime is sufficient to activate satellite cells for muscle repair and reconstruction.

In a preferred embodiment of the invention, the exercise regime is sufficient to stimulate the generation of more mitochondria within myocytes.

In a preferred embodiment of the invention, the exercise regime is sufficient to increase the patient's endurance and power generation capacity.

In a preferred embodiment of the invention, said process is for use with an animal that can benefit from said process.

In a preferred embodiment of the invention, said process is for use in a mammal that can benefit from said process.

28/34

In a preferred embodiment of the invention, said process is for use in a human who can benefit from said process.

In a preferred embodiment of the invention, said process is for use in an elderly human who can benefit from said process.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and aiding prevention of loss of muscle mass, said nutritional composition comprising: whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a metabolite »of BCAA's; a BCAA-rich protein; a protein engineered to enrich the BCAA content; nucleotides or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and aiding prevention of sarcopenia, said nutritional composition comprising: vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; nucleotides or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and aiding prevention of loss of muscle function, said nutritional composition comprising corotenoids; vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25

29/34 hydroxy vitamin D; whey protein or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and aiding in the reduction of inflammation, said nutritional composition comprising vitamin C; omega-3 fatty acids; Lactowolfberry or its combinations.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and aiding in the reduction of subclinical inflammation, said nutritional composition comprising vitamin C; omega-3 fatty acids; Lactowolfberry or its combinations.

In a preferred embodiment of the invention, the nutritional composition to attenuate the loss of functional status and assist in the reduction of calcium loss, said nutritional composition comprising vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25-hydroxy vitamin D; whey protein and protein or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition to attenuate the loss of functional status and assist in reducing oxidative stress, said nutritional composition comprising superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition to attenuate the loss of functional status and assist in the reduction of free radicals, said nutritional composition comprising antioxidants; superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and assisting reduction of lactic acid, said nutritional composition comprising beta alanine.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and assisting the promotion of protein synthesis, said nutritional composition comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein

30/34 of curdled milk; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status and assisting reduction of protein catabolism, said nutritional composition comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status, wherein said nutritional composition comprises at least two of:

1) a nutritional intervention that helps prevent loss of muscle mass;

2) a nutritional intervention that helps prevent sarcopenia;

3) a nutritional intervention that helps prevent loss of muscle function;

4) a nutritional intervention that helps reduce inflammation;

5) a nutritional intervention that helps reduce inflammation

31/34 subclinical;

6) a nutritional intervention that helps to reduce calcium loss;

7) a nutritional intervention that helps to reduce oxidative stress;

8) a nutritional intervention that helps reduce free radicals;

9) a nutritional intervention that helps reduce lactic acid;

10) a nutritional intervention that helps promote protein synthesis;

11) a nutritional intervention that helps reduce protein catabolism.

In a preferred embodiment of the invention, the nutritional composition for attenuating the loss of functional status, wherein said nutritional composition comprises at least two of:

1) a nutritional intervention that helps to reduce muscle mass loss, said nutritional intervention comprising: whey protein, creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof;

2) a nutritional intervention that helps prevent sarcopenia, said nutritional intervention comprising: vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin;

32/34 ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof;

3) a nutritional intervention that helps prevent loss of muscle function, said nutritional intervention comprising corotenoids; vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25hydroxy vitamin D; whey protein or any combination thereof;

4) a nutritional intervention that helps reduce inflammation, said nutritional intervention comprising Vitamin C; omega-3 fatty acids; Lactowolfberry or its combinations;

5) a nutritional intervention that helps to reduce subclinical inflammation, said nutritional intervention comprising Vitamin C; omega-3 fatty acids; Lactowolfberry or its combinations;

6) a nutritional intervention that helps reduce calcium loss, said nutritional intervention comprising vitamin D including vitamin D3, 1,25-dihydroxy vitamin D, 25-hydroxy vitamin D; calcium; whey protein and protein or any combination thereof;

7) a nutritional intervention that helps to reduce oxidative stress, said nutritional intervention comprising superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof.

8) a nutritional intervention that helps in the reduction of free radicals, said nutritional intervention comprising antioxidants; superoxide dismutases; glutathione; glutamine; cysteine; cystine; glycine and whey protein or any combination thereof;

9) a nutritional intervention that helps to reduce lactic acid, said nutritional intervention comprising beta alanine;

10) a nutritional intervention that helps promote synthesis

33/34 of protein, said nutritional intervention comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof;

11) a nutritional intervention that helps to reduce protein catabolism, said nutritional intervention comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof.

In a preferred embodiment of the invention, the nutritional composition further comprises at least one of: protein, carbohydrate, fiber, fat, fatty acid, vitamin, mineral, sugar, carbohydrate, and flavoring agent.

In a preferred embodiment the nutritional intervention is a 125 mL portion which is: energy 200 kcal; 20 g protein (100% whey protein micelles); carbohydrate 7.2 g; fat 7.2 g; vitamin D3 13 micrograms; with added: sodium, chloride, potassium, calcium, molybdenum, fluoride, vitamin A, vitamin E, vitamin K, vitamin C, vitamin B1, vitamin B2, vitamin B6, niacin, folic acid, vitamin B12, pan34 / 34 totogenic acid, biotin, choline, taurine and carnitine.

In a preferred embodiment of the invention, the nutritional composition is complete nutrition.

In a preferred embodiment of the invention, the nutritional composition is incomplete nutrition.

In a preferred embodiment of the invention, the nutritional composition is for short term administration.

In a preferred embodiment of the invention, the nutritional composition is for long-term administration.

In a preferred embodiment of the invention, the nutritional composition is a tube feed.

In a preferred embodiment of the invention, the nutritional composition is a gel.

In a preferred embodiment of the invention, the nutritional composition further comprises a liquid thickener.

In a preferred embodiment of the invention, the process will also include at least one behavioral component such as: interaction with other people, interaction with animals (such as a dog or cats), psychological counseling, tension management, regret management, depression management, and dementia management.

In a preferred embodiment of the invention, the process will also include at least one cognitive component such as: reading, mind stimulation activities, problem solving activities, written activities, puzzles, interactive games and video games.

The foregoing description of various aspects of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form shown, and obviously, many modifications and variations are possible. Such modifications and variations that may be apparent to those skilled in the art are intended to be included within the scope of the invention as defined by the accompanying claims.

Claims (26)

1. Process for mitigating loss of functional status comprising: a) a nutritional intervention that helps to prevent loss of muscle mass, said nutritional intervention comprising: whey protein and at least one of: creatine; antioxidants; bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides; and b) an exercise regime. A process according to claim 1, wherein said whey protein comprises whey protein isolate, whey protein concentrate, whey protein hydrolysates, micelles of whey protein or combinations thereof. A process according to claim 1, wherein the whey protein is whey protein micelles. Process according to claim 1, wherein said nutritional intervention still comprises at least one of corotenoids; D vitamin; or vitamin D3. A process according to claim 1, wherein said nutritional intervention comprises micelles of whey protein and vitamin D3. 6. Process according to claim 1, in which the nutritional intervention helps prevent sarcopenia. 7. Process according to claim 1, in which the nutritional intervention helps prevent loss of muscle function. 8. Process according to claim 1, wherein the interaction 2/4 nutritional intervention helps to reduce inflammation, said nutritional intervention still comprising vitamin C; omega-3 fatty acids; or Lactowolfberry or its combinations. 9. Process according to claim 1, in which the nutritional intervention helps to reduce oxidative stress, said nutritional intervention still comprising: superoxide dismutases; glutathione; glutamine ;. Cysteine; cystine; or glycine or any combination thereof. 10. Process according to claim 1, in which the nutritional intervention promotes protein synthesis, said nutritional intervention still comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; vitamin B12, creatine; antioxidants including bioactive such as lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof. 11. Process according to claim 1, in which the nutritional intervention helps to reduce protein catabolism, said nutritional intervention still comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; vitamin B12, creatine; antioxidants including bioactive such as lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof. 12. Process according to claim 1, wherein the intervention 3/4 nutritional supplement is complete nutrition. Process according to claim 1, wherein the nutritional intervention still comprises a liquid thickener. Process according to claim 1, wherein the nutritional intervention will be administered in one or more doses starting from about one hour before exercise regime to about one hour after exercise regime. 15. Process according to claim 1, in which the exercise regime comprises persistence training or resistance training or persistence training and resistance training. A process according to claim 1, further comprising a behavioral component. 17. The method of claim 1, further comprising a cognitive component. 18. Nutritional composition to attenuate the loss of functional status and to help prevent the loss of muscle mass, said nutritional composition comprising: whey protein and at least one of: creatine; antioxidants; bioactive; lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; x-tocopherol; dihydro ascorbic acid; Vitamin C; D vitamin; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof. 19. Nutritional composition according to claim 18, wherein said whey protein comprises whey protein isolate, whey protein concentrate, whey protein hydrolysates, micelles of whey protein or combinations thereof. 20. Nutritional composition according to claim 18, wherein said whey protein comprises micelles of 4/4 whey protein. 21. Nutritional composition according to claim 18, further comprising vitamin D3. 22. Nutritional composition according to claim 18, comprising whey protein micelles and vitamin D3. 23. Nutritional composition according to claim 18, further comprising vitamins; minerals; zinc; magnesium; folate; vitamins C; b12 vitamin; whey protein; creatine; antioxidants including bioactive such as lycopene; pycnogenol; quercetin; genistein; Soy; epigallocatechin; green tea; lipoic acid; Alpha lipoic acid; xtocopherol; dihydro ascorbic acid; Vitamin C; ubiquinone; coenzyme Q10; leucine; leucine metabolites; alpha hydroxy caproate; beta hydroxy beta methyl butyrate; keto isocaproate; branched chain amino acid (s) (BCAA), a precursor to BCAA; a BCAA metabolite; a BCAA-rich protein; a protein engineered to enrich the BCAA content; or nucleotides or any combination thereof. 24. Nutritional composition according to claim 18, further comprising vitamin C; omega-3 fatty acids; lactowolfberry or its combinations. 25. Nutritional composition according to claim 18, wherein the nutritional composition is complete nutrition. 26. Nutritional composition according to claim 18, wherein the nutritional composition further comprises a liquid thickener.